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Primula Elatior (L.) Hill, Flos 19 September 2012 EMA/HMPC/136583/2012 Committee on Herbal Medicinal Products (HMPC) Assessment report on Primula veris L. and/or Primula elatior (L.) Hill, flos Based on Article 16d(1), Article 16f and Article 16h of Directive 2001/83/EC as amended (traditional use) Final Herbal substance(s) (binomial scientific name of Primula veris L., Primula elatior (L.) Hill, flos the plant, including plant part) Herbal preparation(s) A) Liquid extract (DER 1:1), extraction solvent ethanol 25% v/v B) Comminuted herbal substance Pharmaceutical form(s) Comminuted herbal substance as herbal tea for oral use. Other herbal preparations in liquid and solid dosage forms for oral use. Rapporteur R. Länger Assessor(s) R. Länger 7 Westferry Circus ● Canary Wharf ● London E14 4HB ● United Kingdom Telephone +44 (0)20 7418 8400 Facsimile +44 (0)20 7523 7051 E -mail [email protected] Website www.ema.europa.eu An agency of the European Union © European Medicines Agency, 2013. Reproduction is authorised provided the source is acknowledged. Table of contents Table of contents ................................................................................................................... 2 1. Introduction ....................................................................................................................... 3 1.1. Description of the herbal substance(s), herbal preparation(s) or combinations thereof .. 3 1.2. Information about products on the market in the Member States ............................... 5 1.3. Search and assessment methodology ..................................................................... 6 2. Historical data on medicinal use ........................................................................................ 6 2.1. Information on period of medicinal use in the Community ......................................... 6 2.2. Information on traditional/current indications and specified substances/preparations .... 6 2.3. Specified strength/posology/route of administration/duration of use for relevant preparations and indications ......................................................................................... 7 3. Non-Clinical Data ............................................................................................................... 9 3.1. Overview of available pharmacological data regarding the herbal substance(s), herbal preparation(s) and relevant constituents thereof ............................................................. 9 3.2. Overview of available pharmacokinetic data regarding the herbal substance(s), herbal preparation(s) and relevant constituents thereof ........................................................... 10 3.3. Overview of available toxicological data regarding the herbal substance(s)/herbal preparation(s) and constituents thereof ....................................................................... 10 3.4. Overall conclusions on non-clinical data ................................................................ 11 4. Clinical Data ..................................................................................................................... 11 4.1. Clinical Pharmacology ......................................................................................... 11 4.1.1. Overview of pharmacodynamic data regarding the herbal substance(s)/preparation(s) including data on relevant constituents ........................................................................ 11 4.1.2. Overview of pharmacokinetic data regarding the herbal substance(s)/preparation(s) including data on relevant constituents ........................................................................ 11 4.2. Clinical Efficacy .................................................................................................. 11 4.2.1. Dose response studies...................................................................................... 12 4.2.2. Clinical studies (case studies and clinical trials) ................................................... 12 4.2.3. Clinical studies in special populations (e.g. elderly and children) ............................ 12 4.3. Overall conclusions on clinical pharmacology and efficacy ........................................ 12 5. Clinical Safety/Pharmacovigilance ................................................................................... 12 5.1. Overview of toxicological/safety data from clinical trials in humans ........................... 12 5.2. Patient exposure ................................................................................................ 12 5.3. Adverse events and serious adverse events and deaths .......................................... 12 5.4. Laboratory findings ............................................................................................. 13 5.5. Safety in special populations and situations ........................................................... 13 5.6. Overall conclusions on clinical safety ..................................................................... 14 6. Overall conclusions .......................................................................................................... 14 Annex .................................................................................................................................. 14 Assessment report on Primula veris L. and/or Primula elatior (L.) Hill, flos EMA/HMPC/136583/2012 Page 2/14 1. Introduction 1.1. Description of the herbal substance(s), herbal preparation(s) or combinations thereof • Herbal substance(s) Primula flower (Primulae flos) consists of the whole or cut, dried flowers including the calyx or without calyx of Primula veris L. and /or Primula elatior (L.) Hill. The material complies with the German Deutscher Arzneimittel Codex (DAC 2006). Some references restrict the plant source to the species Primula veris (British Herbal Pharmacopoeia (1974), Pharmacopée Française Xème édition). The haemolytic index (HI) has been used for biological standardisation of saponin containing herbal substances and herbal preparations. Although no longer in use the HI facilitates a comparison between the HI of an herbal substance and preparations thereof allows an estimation of the saponin content. HI of Primulae flos: 35 Constituents (Hänsel et al. 1994, Wichtl 2004): Triterpene saponins (in the sepals up to 2%); structural details are missing. Flavonoids (in the petals up to 3%): apigenine, rutoside (1.3% in Primula elatior, 0.16% in Primula veris), quercetagenin-3-gentiobioside, 3’,4’,5’ – trimethoxyflavone, kaempferol-3-rutinosid and isorhamnetin-3-glucoside present in flowers of Primula elatior only. Carotenoids, traces of essential oil, rosmarinic acid, D- volemitol and other sugar alcohols. OH OH HO O HO O OH O Rutinose OH O OH O Apigenin Rutoside The aerial parts may contain primin and other quinoid compounds, which are responsible for contact allergenic properties of species of the genus Primula (Hausen 1978). Assessment report on Primula veris L. and/or Primula elatior (L.) Hill, flos EMA/HMPC/136583/2012 Page 3/14 OH H H O H HO HO HO OH H3CO H HO H OH O Volemitol Primin • Herbal preparation(s) Herbal preparations with evidence of traditional use: Liquid extract (1:1), extraction solvent 25% ethanol v/v, cited in the British Herbal Pharmacopoeia. Assessor’s comment: no details regarding the DER or the extraction solvent could be found for the tincture which is cited in the publications of the Commission E (cited in Blumenthal et al. 1998) – see section 2.1. • Combinations of herbal substance(s) and/or herbal preparation(s) including a description of vitamin(s) and/or mineral(s) as ingredients of traditional combination herbal medicinal products assessed, where applicable. Primula flower extracts are used in combinations with many other herbal substances/herbal preparations. This monograph refers exclusively to Primula flower. Assessment report on Primula veris L. and/or Primula elatior (L.) Hill, flos EMA/HMPC/136583/2012 Page 4/14 1.2. Information about products on the market in the Member States Regulatory status overview Member State Regulatory Status Comments Austria MA TRAD Other TRAD Other Specify: Combination products Belgium MA TRAD Other TRAD Other Specify: Bulgaria MA TRAD Other TRAD Other Specify: Cyprus MA TRAD Other TRAD Other Specify: Czech Republic MA TRAD Other TRAD Other Specify: Combination products Denmark MA TRAD Other TRAD Other Specify: Estonia MA TRAD Other TRAD Other Specify: Combination products Finland MA TRAD Other TRAD Other Specify: France MA TRAD Other TRAD Other Specify: No products Germany MA TRAD Other TRAD Other Specify: Combination products Greece MA TRAD Other TRAD Other Specify: Hungary MA TRAD Other TRAD Other Specify: Iceland MA TRAD Other TRAD Other Specify: Ireland MA TRAD Other TRAD Other Specify: No products Italy MA TRAD Other TRAD Other Specify: Latvia MA TRAD Other TRAD Other Specify: Liechtenstein MA TRAD Other TRAD Other Specify: Lithuania MA TRAD Other TRAD Other Specify: Luxemburg MA TRAD Other TRAD Other Specify: Malta MA TRAD Other TRAD Other Specify: The Netherlands MA TRAD Other TRAD Other Specify: Norway MA TRAD Other TRAD Other Specify: Poland MA TRAD Other TRAD Other Specify: Portugal MA TRAD Other TRAD Other Specify: Romania MA TRAD Other TRAD Other Specify: Slovak Republic MA TRAD Other TRAD Other Specify: Slovenia MA TRAD Other TRAD Other Specify: Spain MA TRAD Other TRAD Other Specify: No products Sweden MA TRAD Other TRAD Other Specify: No products United Kingdom MA TRAD Other TRAD Other Specify:
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